LEGION 71421215Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556029558), received between Aug 6, 2018 and Jul 4, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Break” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K043440, K093746, K230653); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 4, 2022Break; Loosening of Implant Not Related to Bone-Ingrowth; Break; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A TKR CONSTRUCT HAD BEEN IMPLANTED ON THE PATIENT¿S LEFT KNEE ON (B)(6) 2019, THE PATIENT EXPERIENCED PAIN, INSTABILITY AND THE LOOSENING AND BREAKAGE OF THE CEMENTED PROSTHETIC DEVICE. A REVISION SURGERY WAS CONDUCTED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT. INTRAOPERATIVELY, IT WAS ALSO DISCOVERED THAT THE LOOSE AND BROKEN PROSTHETIC KNEE HAD DONE SUBSTANTIAL NERVE AND SOFT TISSUE DAMAGE TO THE PATIENT¿S LEG. THE IDENTITY OF THE EXPLANTED DEVICES AND THE ONES IMPLANTED IN EXCHANGE IS NOT KNOWN. TO DATE, PATIENT HAS CONSTANT PAIN, SWELLING, AMBULATION DIFFICULTNESS AND INSTABILITY OF HER LEG.

  Patient problems: Ambulation or Postural Difficulties; Arthralgia; Failure of Implant; Joint Laxity; Muscle/Tendon Damage; Nerve Damage; Pain; Swelling/ Edema

  MAUDE report 14907071 ↗
• InjuryAug 6, 2018Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THE PATIENT'S IMPLANT HAS CAUSED THE PATIENT A LOT OF PAIN AND PROSTHETIC JOINT MECHANICAL FAILURE. PATIENT IS WAITING ON APPOINTMENT FOR REVISION SURGERY TO REMOVE ALL DEVICES.

  Patient problems: Injury

  MAUDE report 7754767 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K043440, K093746, K230653. One submission often covers many models, so check the product and lot details in each record.

• Z-0278-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POL
• Z-0277-2025 · Oct 2, 2024 · Open, Classified
  smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 3 LEFT, REF 71421163; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POL
• Z-2621-2023 · Aug 31, 2023 · Open, Classified
  smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
• Z-1951-2021 · May 19, 2021 · Terminated
  LEGION Posterior Stabilized OXINIUM Femoral Component, REF 71421216, Size 6, Left, Nonporous Femoral Component, A/P 65.5 MM, M/L 73 MM, For Cemented Use Only, ZR-2.5NB,Sterile. Kn
• Z-2538-2019 · Jan 15, 2018 · Completed
  LEGION(TM) HEMI STEP TIBIAL WEDGE RK/HK, 5 MM, SIZE 3-4 LT.MDL/RT-LAT, REF 71423432 Product Usage: The constrained knee systems are designed for use in patients in primary and
• Z-0816-2016 · Jan 18, 2016 · Terminated
  LEGION(TM) HEMI STEPPED, TIBIAL SCREW-ON WEDGE, REF 71421147, QTY 1, 5 MM, SIZE 5-6 LT-LAT / RT-MDL; Tibial knee prosthesis, augment.
• Z-1820-2009 · Jan 22, 2009 · Terminated
  LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.
• Z-1819-2009 · Jan 22, 2009 · Terminated
  LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile, Smith & Nephew, Memphis TX 38116. The device is used for Orthopedic Knee Implants.